Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06382389 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-

Study acronym: PROTO-EHPAD
StatusNot Yet Recruiting
PhasePhase 2
Started2026-09
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
minor
Study Status v1
Primary completion date2026-08→2028-09
Completion date2026-08→2028-09
Start date2024-06→2026-09
2024-04-19
minor
Original filing
Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects. Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes. The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure.
Trial Details
NCT Number NCT06382389
Lead Sponsor University Hospital, Tours
Conditions Depression, Neurocognitive Disorders
Enrollment 96 participants
Start Date 2026-09
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-17